Study Measuring Differences in Cognition Due to Sedative Effects of Risperidone and Quetiapine in Stable Bipolar I Outpatients

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 3

Conditions

Bipolar Disorder

Treatments

Drug: risperidone; quetiapine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00097032

CR004654

RIS-OUT-184

Details and patient eligibility

About

The purpose of this study is to determine whether the sedating (causing sleepiness) effects of risperidone or quetiapine alter cognitive (person's ability to think, perceive, recognize, remember, judge, and reason) functioning in subjects with stable Bipolar I Disorder.

Full description

To compare the treatment effects of risperidone and quetiapine on cognitive function, using measures commonly believed to be affected by sedation and at doses typically used in clinical settings in stable bipolar I outpatients.One-half of patients are randomized to treatment sequence risperidone-quetiapine (R-Q), and the other one-half to quetiapine-risperidone (Q-R). Patients randomized to R-Q receive 2 mg of risperidone with dinner the night before testing and placebo with breakfast on the day of testing. After a 6 - 14 day washout period they receive 100 mg quetiapine with dinner the night before their second day of testing and 100 mg with breakfast the day of testing.

Those randomized to Q-R receive the same treatments, but in reverse order. Patients randomized to R-Q receive 2 mg of risperidone with dinner the night before testing and placebo with breakfast on the day of testing. After a 6-14 day washout period they receive 100 mg quetiapine with dinner the night before their second day of testing and 100 mg with breakfast the day of testing. Those randomized to Q-R receive the same treatments, but in reverse order.

Enrollment

30 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria